US20230310070A1

US20230310070A1 - Catheter

Info

Publication number: US20230310070A1
Application number: US18/186,014
Authority: US
Inventors: Kohei SAKAKI; Makoto Kato; Ryo Ishida
Original assignee: Japan Lifeline Co Ltd
Current assignee: Japan Lifeline Co Ltd
Priority date: 2022-03-29
Filing date: 2023-03-17
Publication date: 2023-10-05
Also published as: JP7420854B2; DE102023202417A1; JP2023145853A; CN116889461A; JP2024027137A

Abstract

Provided is a catheter in which a spline changes its shape into an intended shape. A catheter includes a shaft to be inserted into the body, a plurality of splines connected to the distal end side of the shaft, and a distal end member connected to the distal end side of the splines. The plurality of splines include a first spline and a second spline. The first spline and the second spline are located adjacent to each other and their motions are restrained by a first restraining member.

Description

TECHNICAL FIELD

The present disclosure relates to a catheter.

BACKGROUND ART

A catheter is a type of medical devices to be inserted into the body for diagnosis or treatment. As an example, a catheter provided with a shaft and a basket electrode assembly coupled to a distal end of the shaft has been known (for example, see Patent Document 1). Here, the basket electrode assembly includes a plurality of splines. In addition, the basket electrode assembly is configured to change its shape from a contracted shape into an expanded shape by changing the shapes of the splines.

CITATION LIST

Patent Document

- Patent Document 1: JP 2016-507349 T

SUMMARY OF INVENTION

Technical Problem

When the catheter described above is changed in shape with the splines in contact with a body tissue, the interval between the adjacent splines may become too narrow or too wide.
The present disclosure is made in view of the foregoing circumstances, and an object of the present disclosure is to provide a catheter that changes its shape with the adjacent splines held at appropriate intervals.

Solution to Problem

A catheter according to the present disclosure includes a shaft to be inserted into a body, a plurality of splines connected to a distal end side of the shaft, and a distal end member connected to a distal end side of the splines. The plurality of splines include a first spline and a second spline. The first spline and the second spline are located adjacent to each other and motions of the first spline and the second spline are restrained by a first restraining member.
Any combination of the above components and conversions of representation of the present disclosure between a method, a device, a system, and the like are also effective as aspects of the present disclosure.

Advantageous Effects of Invention

The catheter of the present disclosure can change its shape with splines adjacent to each other held at appropriate intervals.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view schematically illustrating an example of a state where a portion near a distal end of a catheter of the present disclosure is changed in shape.

FIG. 2 is a perspective view schematically illustrating another example of a state where the portion near the distal end of the catheter of the present disclosure is changed in shape.

FIG. 3 is a perspective view of members constituting the catheter illustrated in FIG. 1 , from which splines are eliminated.

FIG. 4 is a perspective view of members constituting the catheter illustrated in FIG. 1 , from which a distal end member is eliminated.

FIG. 5 is an enlarged view of an S portion illustrated in FIG. 4 .

FIG. 6 is a side view schematically illustrating an example of the structure of the portion near the distal end of the catheter of the present disclosure.

FIG. 7 is a cross-sectional view taken along the line II-II in FIG. 6 .

FIG. 8 is a cross-sectional view taken along the line III-III in FIG. 6 .

FIG. 9 is a schematic diagram illustrating an example of the overall structure of the catheter of the present disclosure.

DESCRIPTION OF EMBODIMENTS

The present disclosure will be described below based on preferred embodiments with reference to the drawings. The embodiments are illustrative and are not intended to limit the present disclosure. Not all features or combinations of the features described in the embodiments are essential to the present disclosure. The same or similar components, members, and processing operations illustrated in the drawings are denoted by the same reference numerals, and redundant descriptions are omitted as appropriate. The scales and shapes of the parts illustrated in each drawing are set for convenience to facilitate the explanation and should not be construed in a limited manner unless otherwise specified. When the terms “first”, “second”, and the like are used in the specification or claims, these terms do not mean any order or importance unless otherwise specified and are used for distinguishing a configuration from other configurations. Furthermore, some of the members that are not critical in describing the embodiments in the drawings are omitted in illustration.
FIG. 1 is a perspective view schematically illustrating an example of a state where a portion near a distal end of a catheter 1 of the present disclosure is changed in shape. FIG. 2 is a perspective view schematically illustrating another example of a state where the portion near the distal end of the catheter 1 of the present disclosure is changed in shape. As illustrated in FIGS. 1 and 2 , the catheter 1 of the present disclosure includes a shaft 2 to be inserted into the body, a plurality of splines 3 connected to a distal end side of the shaft 2, and a distal end member 4 connected to a distal end side of the splines 3.
The shaft 2 may be an elongated circular tubular member. The length of the shaft 2 is, for example, 800 mm to 1800 mm. The outer diameter of the shaft 2 is, for example, 2.0 mm to 5.0 mm. The material forming the shaft 2 may be a material having flexibility and biocompatibility. For example, the shaft 2 is formed of a known resin such as polyolefin or polyamide.
The spline 3 is a member that connects the shaft 2 and the distal end member 4. The spline 3 may be a circular tubular member like the shaft 2. The length of the spline 3 when extended in a linear manner is, for example, 20 mm to 50 mm. The outer diameter of the spline 3 is, for example, 0.5 mm to 2.0 mm. The material forming the spline 3 is any material having flexibility and biocompatibility. For example, the spline 3 is formed of a known resin such as polyolefin or polyamide, like the shaft 2.
The splines 3 include at least a first spline 3 a and a second spline 3 b that are adjacent to each other. FIGS. 1 and 2 illustrate an example in which the number of splines 3 is six. Specifically, an example is illustrated in which the first spline 3 a is adjacent to the second spline 3 b, the second spline 3 b to a third spline 3 c, the third spline 3 c to a fourth spline 3 d, the fourth spline 3 d to a fifth spline 3 e, the fifth spline 3 e to a sixth spline 3 f, and the sixth spline 3 f to the first spline 3 a. The splines 3 are disposed separated from each other in a plane orthogonal to a central axis of the shaft 2.
The splines 3 are connected to the shaft 2. For example, a portion (proximal end portion) including a proximal end of the spline 3 is inserted into the distal end side of the shaft 2. The proximal end portion of the spline 3 and the shaft 2 are joined to each other by a known joining method such as welding or bonding with an adhesive.
The spline 3 is configured to change its shape in accordance with a shape changing operation described below. Specifically, the shape of each spline 3 is changed between an unexpanded shape (a contracted shape) in which each spline 3 is not expanded along the central axis of the shaft 2 and an expanded shape (a developed shape) in which each spline 3 is expanded along the central axis of the shaft 2 from the unexpanded shape. Examples of the unexpanded shape may include a “petal shape” (see FIG. 2 ) as will hereinafter be described in detail. Meanwhile, examples of the expanded shape may include a “basket shape” (see FIG. 1 ) in which each spline 3 is expanded from the petal shape along the central axis of the shaft 2.
FIG. 3 is a perspective view of members constituting the catheter 1 illustrated in FIG. 1 , from which the splines 3 are eliminated. FIG. 4 is a perspective view of members constituting the catheter 1 illustrated in FIG. 1 , from which the distal end member 4 is eliminated. FIG. 5 is an enlarged view of the S portion illustrated in FIG. 4 . As illustrated in FIGS. 3 to 5 , motions of the first spline 3 a and the second spline 3 b are restrained by a first restraining member 6 a. Here, that motions of the first spline 3 a and the second spline 3 b are restrained means that when the first spline 3 a and the second spline 3 b are changed in shape, the first spline 3 a and the second spline 3 b change their shapes while holding an appropriate interval therebetween. Note that the interval here is the shortest distance between the distal end side of the first spline 3 a and the distal end side of the second spline 3 b. Thus, even if the shape changing operation is performed in a state where the first spline 3 a is in contact with a body tissue, the first spline 3 a and the second spline 3 b change its shape while holding an appropriate interval therebetween via the first restraining member 6 a. Since satisfying such a configuration, the catheter 1 of the present disclosure can change its shape into a desired shape (unexpanded shape or expanded shape) such that the splines 3 adjacent to each other are held at appropriate intervals.
The first restraining member 6 a may be of any shape, structure, and material as long as the member can restrain motions of the first spline 3 a and the second spline 3 b. The first restraining member 6 a is wire, for example. The material forming the first restraining member 6 a that is wire may be a shape-memory alloy such as a nickel-titanium alloy.
The first restraining member 6 a may include a first end and a second end. At least a portion on the first end side of the first restraining member 6 a is located within the first spline 3 a, and at least a portion on the second end side of the first restraining member 6 a may be located within the second spline 3 b. The first restraining member 6 a may include a protruding portion 15 a protruding such that it is closer to the distal end of the catheter 1 than a distal end of the first spline 3 a and a distal end of the second spline 3 b are. Here, at least a portion on the first end side is a continuous portion having a certain length from the first end side of the protruding portion 15 a in the first restraining member 6 a. At least a portion of the second end side is a continuous portion having a certain length from the second end side of the protruding portion 15 a in the first restraining member 6 a.
The first end of the first restraining member 6 a may be located closer to a proximal end of the catheter 1 than a proximal end of the first spline 3 a is. Meanwhile, the second end of the first restraining member 6 a may be located closer to the proximal end of the catheter 1 than a proximal end of the second spline 3 b is. When such a configuration is satisfied, the first restraining member 6 a serves as a framework that maintains the shapes of the first spline 3 a and the second spline 3 b.
In a case where the first restraining member 6 a is wire, the protruding portion 15 a may have a shape bent in a U-shape. When the first spline 3 a or the second spline 3 b is changed in shape, the first restraining member 6 a is also changed in shape along with the spline. At this time, the stress generated by the change in shape is concentrated in the protruding portion 15 a. When the protruding portion 15 a has a shape bent in a U-shape, the stress described above can be effectively relieved, and even when changing in shape is repeatedly performed, the protruding portion 15 a is less likely to break.
In the embodiment described above, the first spline 3 a and the second spline 3 b are described as an example; however, the same applies to the other splines 3. In other words, motions of the adjacent splines 3 may be restrained by one restraining member 6. Specifically, motions of the second spline 3 b and the third spline 3 c may be restrained by a second restraining member 6 b. Motions of the third spline 3 c and the fourth spline 3 d may be restrained by a third restraining member 6 c. Motions of the fourth spline 3 d and the fifth spline 3 e may be restrained by a fourth restraining member 6 d. Motions of the fifth spline 3 e and the sixth spline 3 f may be restrained by a fifth restraining member 6 e. Motions of the sixth spline 3 f and the first spline 3 a may be restrained by a sixth restraining member 6 f.
FIG. 6 is a side view schematically illustrating an example of the structure of the portion near the distal end of the catheter 1 of the present disclosure. FIG. 7 is a cross-sectional view taken along the line II-II in FIG. 6 . As illustrated in FIG. 7 , the first spline 3 a may have a multi-lumen structure. Specifically, the first spline 3 a includes four lumens 7 (7 a 1, 7 b 1, 7 c 1, 7 d 1) extending from the distal end to the proximal end along a central axis of the first spline 3 a. Here, the lumens 7 a 1, 7 b 1 are located closer to the central axis of the shaft 2 than the lumens 7 c 1, 7 d 1 are. The lumens 7 b 1, 7 c 1 are located closer to the second spline 3 b than the lumens 7 a 1, 7 d 1 are.
The second spline 3 b may have a multi-lumen structure like the first spline 3 a. Specifically, the second spline 3 b includes four lumens 7 (7 a 2, 7 b 2, 7 c 2, 7 d 2) extending from the distal end to the proximal end along a central axis of the second spline 3 b. Here, the lumens 7 a 2, 7 b 2 are located closer to the central axis of the shaft 2 than the lumens 7 c 2, 7 d 2 are. The lumens 7 a 2, 7 d 2 are located closer to the first spline 3 a than the lumens 7 c 2, 7 b 2 are.
The first end side of the first restraining member 6 a may be inserted into the lumen 7 c 1 of the first spline 3 a. Meanwhile, the second end side of the first restraining member 6 a may be inserted into the lumen 7 d 2 of the second spline 3 b. As just described, the first restraining members 6 a are inserted in the lumens 7 c 1, 7 d 2, located separated from the central axis side of the shaft 2 and closest to each other, of the lumens 7 in the first spline 3 a and the second spline 3 b, and thus the first spline 3 a and the second spline 3 b are held at a more appropriate interval.
In the embodiment described above, the first spline 3 a, the second spline 3 b, and the first restraining member 6 a are described as an example; however, the same applies to the other splines 3 and the other restraining members 6.
Each spline 3 may include one or more electrodes 5 as illustrated in FIG. 6 . The electrode 5 is a ring-shaped electrode for potential measurement or cauterization. The electrodes 5 included in the same spline 3 are disposed separated from each other along the longitudinal direction of the spline 3. In this case, the intervals between the adjacent electrodes 5 may be uniform or may be different. The number of electrodes 5 included in each of the splines 3 may be the same or may be different.
The electrode 5 is formed of a material having conductivity. For example, the electrode 5 is formed of a metal which has a good electrical conductivity, such as aluminum (Al), copper (Cu), stainless steel, gold (Au), or platinum (Pt). The length of the electrode 5 is, for example, 0.5 mm to 2.0 mm. The outer diameter of the electrode 5 is equivalent to the outer diameter of the spline 3, and is, for example, 0.5 mm to 1.6 mm.
A conductive wire is individually and electrically connected to each of the electrodes 5. The conductive wire passes through the spline 3, the shaft 2, and a handle 8 described below to be connected via the handle 8 to an external power supply device. For example, the conductive wires connected to the respective electrodes 5 of the first spline 3 a pass through the lumen 7 a 1 or the lumen 7 b 1 of the first spline 3 a while being electrically isolated from each other. Note that the same applies to the splines 3 other than the first spline 3 a.
As illustrated in FIGS. 2 and 4 , the distal end member 4 may cover a portion (distal end portion) including the distal end of the first spline 3 a, a portion (distal end portion) including the distal end of the second spline 3 b, and the protruding portion 15 a of the first restraining member 6 a. In other words, the distal end portion of the first spline 3 a, the distal end portion of the second spline 3 b, and the protruding portion 15 a of the first restraining member 6 a may be covered by the distal end member 4. The distal end member 4 may have any shape, and has a cap shape, for example. The distal end member 4 may be formed of any material, and is formed of a known resin such as nylon, nylon elastomer, or polycarbonate, or a known metal such as stainless steel. Note that the distal end member 4 may cover all of the distal end portions of the splines 3 and the protruding portions 15 of the restraining members 6.
FIG. 8 is a cross-sectional view taken along the line III-III in FIG. 6 . As illustrated in FIG. 8 , in plan view of a lower surface of the distal end member 4, a wall portion forming an inner surface of the distal end member 4 may have a first recess portion 9 a and a second recess portion 9 b that are located adjacent to each other. At least a portion of the distal end portion of the first spline 3 a may be located in the first recess portion 9 a, and at least a portion of the distal end portion of the second spline 3 b may be located in the second recess portion 9 b. Here, that at least a portion of the distal end portion of the first spline 3 a is located in the first recess portion 9 a means that in plan view of the lower surface of the distal end member 4, a region of the first recess portion 9 a includes a portion overlapped by the first spline 3 a. Meanwhile, that at least a portion of the distal end portion of the second spline 3 b is located in the second recess portion 9 b means that in plan view of the lower surface of the distal end member 4, a region of the second recess portion 9 a includes a portion overlapped by the second spline 3 b. In a case where such a configuration is satisfied, when the first spline 3 a and the second spline 3 b are changed in shape, the distal end portion of the first spline 3 a and the distal end portion of the second spline 3 b can be prevented from becoming misaligned, by the first recess portion 9 a and the second recess portion 9 b.
The shape of the first recess portion 9 a and the second recess portion 9 b is, for example, a semicircle in plan view of the lower surface of the distal end member 4. The wall portion forming the first recess portion 9 a may be in contact with but need not be in contact with the first spline 3 a. Similarly, the wall portion forming the second recess portion 9 b may be in contact with but need not be in contact with the second spline 3 b. Note that FIG. 8 illustrates an example in which the wall portion forming the inner surface of the distal end member 4 has six recess portions 9. As just described, the wall portion forming the inner surface of the distal end member 4 may have the recess portions 9 corresponding to the respective splines 3.
The interior of the distal end member 4 may be filled with an adhesive. When such a configuration is satisfied, the first spline 3 a, the second spline 3 b, and the first restraining member 6 a are firmly joined to each other by the adhesive. Therefore, the first spline 3 a and the second spline 3 b are held at a more appropriate interval.
As illustrated in FIG. 5 , the distal end member 4 may include a bundling member 10 that bundles the protruding portion 15 a of the first restraining member 6 a. Here, that bundling the protruding portion 15 a means that bundling the protruding portion 15 a such that the protruding portion 15 a does not move in a planar direction orthogonal to the central axis of the shaft 2. When such a configuration is satisfied, the twisting of the first restraining member 6 a is suppressed by the bundling member 10, and thus the first spline 3 a and the second spline 3 b can be changed in shape via the first restraining member 6 a effectively in conjunction with each other. Note that the bundling member 10 may bundle the protruding portions 15 of all of the restraining members 6.
The bundling member 10 may be of any shape, structure, and material as long as the bundling member 10 can bundle the protruding portion 15 a. For example, the shape of the bundling member 10 is a plate including a first surface (top surface) and a second surface (lower surface) that is the back surface of the first surface. The second surface faces a distal end surface of the first spline 3 a and a distal end surface of the second spline 3 b. The bundling member 10 is provided with a through-hole 16 a penetrating from the first surface to the second surface. The protruding portion 15 a of the first restraining member 6 a is inserted into the through-hole 16 a. A third surface (side surface) that connects the first surface and the second surface of the bundling member 10 may have any shape that corresponds to the wall portion forming the inner surface of the distal end member 4. Specifically, the third surface may have a shape that includes protrusion portions corresponding to the respective recess portions 9 of the distal end member 4. The material forming the bundling member 10 may be a material having high rigidity. For example, the bundling member 10 is formed of a known metal such as stainless steel. Note that the bundling member 10 may be provided with through-holes 16 corresponding to the protruding portions 15 of the respective restraining members 6.
The through-hole 16 a may have any shape as long as the protruding portion 15 a of the first restraining member 6 a can be inserted into the through-hole 16 a. For example, the shape of the through-hole 16 a is an elliptical shape in plan view seen from the first surface side of the bundling member 10. Note that the same may apply to the other through-holes 16.
FIG. 9 is a schematic diagram illustrating an example of the overall structure of the catheter 1 of the present disclosure. As illustrated in FIG. 9 , the catheter 1 may be provided with the handle 8 connected to the proximal end side of the shaft 2. The handle 8 is a portion that an operator (physician) grips (holds) when using the catheter 1. The handle 8 may include a handle body 11 mounted on the proximal end side of the shaft 2, a rotational operation portion 12, and a slide member 13.
The handle body 11 corresponds to a portion that is actually held by the operator. The handle body 11 may have any shape. The handle body 11 has a shape extending along the central axis of the shaft 2, for example. In addition, the handle body 11 is formed of, for example, a known resin such as polycarbonate, polyacetal, or ABS.
The rotational operation portion 12 is a portion that is operated (rotated) when a portion near the distal end of the shaft 2 is bent (warped) in both directions. Proximal ends of a pair of pull wires are fixed to the rotational operation portion 12 in the handle body 11. Distal ends of the pair of pull wires pass through the handle body 11 and the shaft 2 to be fixed to the distal end side of the shaft 2. Thus, when the rotational operation portion 12 is operated (rotated), the pull wires are pulled toward the proximal end side, and the distal end side of the shaft 2 to which the distal ends of the pull wires are fixed is bent (warped).
The slide member 13 is a portion that is changed in shape (slid) by the operator at the time of changing the shape of the spline 3 between the unexpanded shape (contracted shape) and the expanded shape (developed shape) that are described above. The slide member 13 is slidable along the central axis of the shaft 2 in the handle body 11.
A proximal end of a shape changing member 14 is fixed to the slide member 13. A distal end of the shape changing member 14 passes through the shaft 2 from the inside of the handle body 11 to be fixed to the inside of the distal end member 4. The slide member 13 is movable to any position in the handle body 11 along the central axis of the shaft 2. Therefore, in accordance with the position of the slide member 13, the shape of the spline 3 can be changed to the aforementioned unexpanded shape (contracted shape), the aforementioned expanded shape (developed shape), or any intermediate shape between the unexpanded shape and the expanded shape.
The shape changing member 14 may be of any shape, structure, and material as long as the shape changing member 14 is an elongated member. For example, the shape changing member 14 is wire thicker than the restraining member 6.
The embodiment of the present disclosure has been described in detail. The embodiment described above is merely a specific example for carrying out the present disclosure. The content of the embodiment is not intended to limit the technical scope of the present disclosure. Many design changes such as changes, additions, and deletions of components can be made in the scope that does not depart from the spirit of the present disclosure specified in the claims. A new embodiment with design changes has effects of combined embodiments and variations thereof. Any combination of components included in each embodiment is also effective as an aspect of the present disclosure. Hatching in sections of the drawings does not limit the material of a hatched object.

REFERENCE SIGNS LIST

- 1: Catheter
- 2: Shaft
- 3, 3 a, 3 b, 3 c, 3 d, 3 e, 3 f: Spline
- 4: Distal end member
- 5: Electrode
- 6, 6 a, 6 b, 6 c, 6 d, 6 e, 6 f: Restraining member
- 7, 7 a 1, 7 b 1, 7 c 1, 7 d 1, 7 a 2, 7 b 2, 7 c 2, 7 d 2: Lumen
- 8: Handle
- 9, 9 a, 9 b: Recess portion
- 10: Bundling member
- 11: Handle body
- 12: Rotational operation portion
- 13: Slide member
- 14: Shape changing member
- 15, 15 a, 15 b, 15 c, 15 d, 15 e, 15 f: Protruding portion
- 16, 16 a: Through-hole

Claims

1. A catheter comprising:

a shaft to be inserted into a body;

a plurality of splines connected to a distal end side of the shaft; and

a distal end member connected to a distal end side of the splines, wherein

the plurality of splines include a first spline and a second spline, and

the first spline and the second spline are located adjacent to each other and motions of the first spline and the second spline are restrained by a first restraining member.

2. The catheter according to claim 1, wherein

the first restraining member includes a first end and a second end,

at least a portion on the first end side of the first restraining member is located within the first spline,

at least a portion on the second end side of the first restraining member is located within the second spline, and

the first restraining member includes a protruding portion protruding such that the protruding portion is closer to a distal end of the catheter than a distal end of the first spline and a distal end of the second spline are.

3. The catheter according to claim 2, wherein the distal end member covers a distal end portion of the first spline, a distal end portion of the second spline, and the protruding portion of the first restraining member.

4. The catheter according to claim 3, wherein

in plan view of a lower surface of the distal end member, a wall portion forming an inner surface of the distal end member includes a first recess portion and a second recess that are located adjacent to each other,

at least a portion of the distal end portion of the first spline is located in the first recess portion, and

at least a portion of the distal end portion of the second spline is located in the second recess portion.

5. The catheter according to claim 4, wherein an interior of the distal end member is filled with an adhesive.

6. The catheter according to claim 3, wherein the distal end member includes a bundling member bundling the protruding portion of the first restraining member.

7. The catheter according to claim 6, wherein

the bundling member has a plate shape including a first surface and a second surface that is a back surface of the first surface,

the second surface faces a distal end surface of the first spline and a distal end surface of the second spline, and

the bundling member is provided with a through-hole which penetrates from the first surface to the second surface and into which the protruding portion of the first restraining member is inserted.

8. The catheter according to claim 1, wherein the first restraining member is wire.

9. The catheter according to claim 1, wherein the first restraining member is provided separately from the distal end member and the shaft.

10. A catheter comprising:

a shaft to be inserted into a body;

a plurality of splines connected to a distal end side of the shaft; and

a distal end member connected to a distal end side of the splines, wherein

motions of the splines adjacent to each other are restrained by one restraining member.